On February 8, 2016 Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical company focused on the discovery and development of direct-acting antivirals that address infections that have limited therapeutic options, reported that the first patient has been dosed in a Phase 2 double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability and efficacy of BTA074 5% gel in male and female patients with condyloma, or anogenital warts, caused by human papillomavirus (HPV) types 6 & 11 (Press release, Nabi Biopharmaceuticals, FEB 8, 2016, View Source [SID:1234508993]).

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"We are excited to progress BTA074 into a well-powered proof-of-concept study. The currently approved topical treatments for condyloma lack consistent efficacy and cause a considerable amount of undesirable local skin reactions, such as erosions and edema, often leading to the need to stop treatment. With this larger Phase 2 study, we hope to further validate the clinical activity of BTA074 seen in its earlier Phase 2 trial, which showed evidence of overall clearance and a benign side effect profile," remarked Joseph M. Patti, PhD, president and chief executive officer at Biota. "We now have three direct-acting antiviral programs in the clinic, each of which has the potential to help patients by attacking the root cause of their viral infections."

BTA074 is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, and is designed to prevent HPV DNA replication. The Phase 2 trial is expected to enroll approximately 210 patients with anogenital warts and will have a 2-to-1 randomization of BTA074 5% gel to placebo gel. The patients will be dosed twice daily for up to 16 weeks. The primary efficacy objective is to determine the complete clearance rate for baseline anogenital warts from the commencement of therapy to the end of the treatment period. Secondary efficacy endpoints include various assessments of clearance and wart area reduction for both baseline warts and post-baseline emergent warts.

On February 8, 2016 Pfizer Inc. (NYSE: PFE) reported the executive leadership team for the combined Pfizer and Allergan plc (NYSE: AGN) business following the close of the proposed transaction (Press release, Pfizer, FEB 8, 2016, View Source [SID:1234509009]).

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As previously announced, following the closing, Brent Saunders will become President and Chief Operating Officer of the combined company with responsibility for the oversight of Pfizer and Allergan’s combined commercial businesses, manufacturing and strategy functions.

Effective immediately and through the closing of the transaction Pfizer’s Global Innovative Pharma (GIP) business and its Vaccines, Oncology and Consumer (VOC) business will operate separately under the leadership of Albert Bourla, currently Group President, VOC. Upon the closing of the transaction, the Vaccines and Oncology businesses will be combined with the GIP business, and Albert Bourla will become Group President, Global Innovative Pharma, leading all of these businesses.

In addition, following the close of the transaction, the combined company will create a new operating segment named Global Specialty and Consumer Brands that will include Pfizer’s Consumer Healthcare unit and Allergan’s ophthalmology and aesthetics businesses, and Botox Therapeutic and Cosmetic. Bill Meury, currently Executive Vice President and President Branded Pharma at Allergan, will become Group President, Global Specialty and Consumer Brands, Pfizer.

After the close of the proposed transaction, Pfizer will continue to manage the combined company’s commercial operations through two distinct businesses: an Innovative Products business and an Established Products business. The Innovative Products business will be composed of two operating segments: the Global Innovative Pharmaceutical and the Global Specialty and Consumer Brands segment. The Established Products business will continue to be led by John Young, and consist of the Global Established Pharmaceutical segment, including all legacy Hospira commercial operations.

Upon the close of the transaction, the following executives will be members of the company’s executive leadership team, reporting to Brent Saunders:

Albert Bourla, Group President, Global Innovative Pharma
Tony Maddaluna, Executive Vice President, President Pfizer Global Supply
Bill Meury, Group President, Global Specialty and Consumer Brands
Laurie Olson, Executive Vice President, Strategy, Portfolio and Commercial Operations
John Young, Group President, Global Established Pharma
The following Pfizer executives are continuing in their roles reporting to Ian Read, Pfizer Chairman and Chief Executive Officer:

Frank D’Amelio – Executive Vice President, Business Operations and Chief Financial Officer
Mikael Dolsten – President, Worldwide Research and Development
Chuck Hill – Executive Vice President, Worldwide Human Resources
Rady Johnson – Executive Vice President, Chief Compliance and Risk Officer
Doug Lankler – Executive Vice President, General Counsel
Freda Lewis-Hall – Executive Vice President, Chief Medical Officer
Sally Susman – Executive Vice President, Corporate Affairs
"We are creating an executive team that has deep industry knowledge, a proven track record of success and an unwavering commitment to the patients we serve. I look forward to working with these outstanding leaders to achieve the full potential of this combination and fulfill our mission of becoming the premier biopharmaceutical company in our industry," said Ian Read, Chairman and Chief Executive Officer of Pfizer. "We are designing the combined company to preserve and enhance our option to potentially separate the innovative and established businesses into separate companies in the future, and continue to expect to make a decision about any potential separation by no later than the end of 2018."

Pfizer also announced that Geno Germano, Group President, Global Innovative Pharma Business, will be leaving the company.

"We thank Geno for his many contributions to Pfizer’s business over the past seven years," continued Read. "Under Geno’s leadership we have laid the foundation for the growth potential of our vaccines and oncology businesses, strengthened our in-line portfolio with products like Enbrel, Xeljanz and Eliquis and improved our innovative late-stage pipeline with programs like bococizumab and tanezumab."

Pfizer and Allergan will continue to operate as two separate companies until the close of the transaction, which is expected in the second half of 2016, and is subject to certain conditions, including: receipt of regulatory approval in certain jurisdictions, including the United States and European Union; the receipt of necessary approvals from both Pfizer and Allergan shareholders; and the completion of Allergan’s pending divestiture of its generics business to Teva Pharmaceuticals Industries Ltd.

On February 5, 2016 Elios Therapeutics begins enrollment of phase I/IIa melanoma trial (NCT02678741) combining approved check point inhibitors with the Elios personalized cancer vaccine (Press release, Elios Therapeutics, FEB 5, 2016, View Source [SID:SID1234515509]).

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The trial attempts to address the unmet need of metastatic melanoma patients who fail to respond to checkpoint inhibitors(CPIs) alone
The trial will underscore the natural synergies between vaccines and CPIs
The trial will use Elios’ autologous tumor lysate (TL), particle loaded (PL), dendritic cell (DC) vaccine (TLPLDC) currently in a randomized phase IIb adjuvant trial

Elios Therapeutics, LLC, has received FDA approval to proceed with a 45-patient study that will combine the company’s novel autologous vaccine technology (TLPLDC) with standard-of-care "check point inhibitors" in metastatic melanoma patients with stable or slowly progressing disease. The study will be conducted at leading clinical research sites in the U.S. and be led by Steven O’Day, MD, Professor of Medical Oncology, Director of Immuno-Oncology, Director of Clinical Research, The John Wayne Cancer Institute, Providence Saint John’s Medical Center, Santa Monica, California.

Checkpoint inhibitors such as Yervoy, Keytruda, and Opdivo are approved for use in patients with metastatic melanoma. A small subset of patients treated with such ‘checkpoint inhibitors’ will achieve a clinical complete response; however, the majority of patients will not. "While some patients may experience partial responses or stable disease, most will see their disease progress," commented Tom Wagner, PhD, the TLPLDC vaccine inventor: "Checkpoint inhibitors work on a patient’s existing T Cell population. In order for checkpoint inhibitors to be effective, the patient must have corresponding T Cells that can recognize and attack their specific disease. It is likely that patients who do not respond or partially respond to this therapy do not have any or enough specifically-corresponding T Cells to overcome their disease. The way you create those T Cells is through autologous vaccination. Our vaccine creates a specific immune response without toxicity in a production environment that does not carry the financial burden of other therapies – possibly a perfect combination."

In early clinical studies, the TLPLDC vaccine has shown effectiveness in both the adjuvant and metastatic settings. Elios is also currently enrolling a phase II(b) 120-patient adjuvant trial in stage III and IV (resected) melanoma patients (NCT#02301611). "The unique way that the TLPLDC vaccine presents antigen to the immune system with or without other therapeutic agents and the logistical ease with which the vaccine is produced makes it easily deployed in clinical settings," said George Peoples, MD, FACS, Chief Medical Officer at Elios. "We are excited about our progress in the ongoing adjuvant trial and encouraged that adding the autologous TLPLDC vaccine to existing check point inhibitor therapy will significantly improve patient outcomes in the metastatic setting."

"Immune Checkpoint Inhibitors have revolutionized the treatment of melanoma and other cancers," said Steven O’Day, MD. "Despite durable responses and prolonged survival in many patients the majority of patients do not respond to single agent checkpoint blockade. Novel combinations of checkpoint inhibitors with other immune modulators will be critical as we build on our new found success. Novel Vaccines offer a potential additive or synergistic role in combination with PD1 inhibitors with a favorable toxicity profile."

Initial readouts for (i) the 45 patient phase I/II(a) trial of the TLPLDC vaccine in combination with checkpoint inhibitors in metastatic melanoma patients, and (ii) the 120 patient phase II(b) adjuvant trial in stage III and IV (resected) patients to prevent recurrence are both expected in December 2016.

On February 5, 2015 Biota Pharmaceuticals, Inc. (NASDAQ: BOTA) reported its financial results for the three month period ended December 31, 2015, which is the second quarter of the Company’s 2016 fiscal year, and also provided an update on recent corporate developments (Filing, 8-K, Nabi Biopharmaceuticals, FEB 5, 2016, View Source [SID:1234508985]).

"I am very pleased today to report that significant progress is being made with our antiviral pipeline for respiratory indications and we remain on track to have Phase 2 data readouts in the second half of the year from both the HRV and RSV programs. Our oral RSV fusion inhibitor, BTA585, successfully completed a robust Phase 1 single ascending dose study showing a favorable safety and pharmacokinetic profile. We are nearing completion of the Phase 1 multiple ascending dose study and plan to initiate the Phase 2 RSV challenge study next quarter. Additionally we are progressing with enrollment in the Phase 2b SPIRITUS trial of vapendavir and anticipate top-line data in the second half of this year. Not only is this our lead program but it is the most advanced direct-acting antiviral in the field targeting HRV and has the potential to treat problematic upper respiratory infections in the almost 11 million moderate-to-severe asthmatics in the U.S.," stated Joseph M. Patti, PhD, president and chief executive officer at Biota Pharmaceuticals.

"I am glad to report that we have begun screening patients for the Phase 2 study of BTA074, our first-in-class direct-acting antiviral for the treatment of condyloma caused by HPV types 6 & 11, which is the most common manifestation of HPV infection and also the most common sexually-transmitted viral disease worldwide. Current topical treatments do not act on the virus directly so there is a need for a therapy with improved efficacy and reduced local skin reactions to address this contagious infection."

Recent Highlights
Announced positive Phase 1 data for BTA585. The top-line results were from a blinded, placebo-controlled single ascending dose study, which tested doses of up to 800 mg of BTA585, an oral fusion inhibitor in development for the treatment and prevention of respiratory syncytial virus (RSV) infections. Findings included:

● No serious or severe adverse events

● Low incidence of adverse events

● Pharmacokinetic (PK) data demonstrated that all doses of 100 mg or greater achieved BTA585 plasma levels that exceeded the mean EC50 of RSV clinical isolates for 24 hours. The EC50 represents the concentration of drug that is required for 50% inhibition of viral replication in vitro

● BTA585 plasma Cmax was rapidly achieved at approximately one hour following oral dosing and the half-life (T1/2) was approximately five to six hours across the dose range

● Dosing of BTA585 with a high fat meal did not adversely affect the PK

Commenced dosing in Phase 1 multiple ascending dose (MAD) study of BTA585. This study will evaluate the safety and PK of BTA585 in healthy volunteers following seven days of oral dosing. Top-line data is anticipated to be available in the first quarter of 2016.

Enrollment on track for Phase 2b SPIRITUS trial for vapendavir. Top-line data are expected in the second half of 2016 from the multi-center, randomized, double-blind, placebo-controlled dose-ranging study in moderate-to-severe adult asthmatics with symptomatic human rhinovirus (HRV) and a history of asthma exacerbation from colds.

Corporate Updates

Appointed Mark P. Colonnese as Executive Vice President and Chief Financial Officer on November 2, 2015. The Company announced the appointment of Mark Colonnese as Executive Vice President and Chief Financial Officer. Mr. Colonnese has held a number of senior executive positions in the pharmaceutical industry and, most recently, was Chief Financial Officer of Stealth BioTherapeutics, Inc.

Financial Results for the Three Month Period Ended December 31, 2015

The Company reported a net loss of $6.5 million for the three month period ended December 31, 2015, as compared to net income of $6.5 million in the same quarter of the prior fiscal year. Basic and diluted net loss per share was $0.17 for the three month period ended December 31, 2015, as compared to a basic and diluted net income per share of $0.19 in the same period of 2014.

Revenue decreased to $1.7 million for the three month period ended December 31, 2015 from $13.9 million in the same period in 2014 due to a $4.8 million decrease in royalty revenues, related to a larger Relenza government stockpile order received in the prior year, as well as lower seasonal sales of Relenza and Inavir reflecting an earlier than normal flu season in 2014, and $7.4 million decrease in revenue from services as a result of the termination of the Company’s contract with BARDA in 2014.

Cost of revenue decreased to zero for the three month period ended December 31, 2015 from $1.6 million in the same period last year due to the termination of the Company’s contract with BARDA in 2014.

Research and development expense increased to $6.3 million for the three month period ended December 31, 2015 from $4.8 million in the same period in 2014. The $1.5 million increase was the result of a $2.8 million increase in clinical costs related to the ongoing Phase 2b SPIRITUS trial for vapendavir; the Phase 1 SAD and MAD trials for BTA585; and startup expenses for the Phase 2 trial for BTA074. These costs were offset in part by a $0.8 million decrease in compensation expenses and a decrease of $0.5 million in depreciation and facility related expenses associated with the closure of the Company’s early-stage research facility in March 2015.

General and administrative expense decreased to $2.1 million for the three month period ended December 31, 2015 from $2.6 million in the same period in 2014, due largely to lower compensation expenses as a result of administrative staff reductions related to the facility closure in March 2015.

The Company held $57.2 million in cash, cash equivalents, and short and long-term investments as of December 31, 2015.

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On February 3, 2016 Advaxis, Inc. (NASDAQ: ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that it has entered into a co-development and commercialization agreement with Especificos Stendhal SA de CV ("Stendhal"), for Advaxis’ lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated cancers (Filing, 8-K, Advaxis, FEB 4, 2016, View Source [SID:1234508970]). Stendhal is a privately held Latin American specialty pharmaceutical company that partners with leading drug companies to deliver effective solutions for life-threatening diseases in Latin American markets.

Under the terms of the Agreement, Stendhal will pay $10 million toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs. Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Additionally, Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Advaxis and Stendhal will share profits on a pre-determined basis.

Stendhal has a long history of partnering with leading pharmaceutical companies to bring therapies for HIV, infectious disease, and neurologic and cardiovascular disease to its Latin American markets. This new partnership with Advaxis will expand its growing portfolio in oncology and is one of the first of its kind in Latin America to make cancer immunotherapies available in the region.

HPV-related cancer is a looming public health issue in Latin America. According to the World Health Organization, cervical cancer mortality rates are three times higher in Latin America and the Caribbean than in North America. More than 83,000 women are diagnosed annually and, without intervention, mortality is projected to increase to 45 percent by 2030. HPV is also prevalent in 90.4 percent of anal cancer in Latin America and the Caribbean.

"We’re pleased to announce our agreement with Stendhal, which enables us to greatly expand the clinical program for, and the potential impact of, axalimogene filolisbac in HPV-related cancers," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We now have the potential to address an important unmet medical need in an area of the world where the rate of HPV-associated cancers is unfortunately extremely high."

"Our mission is to bring new treatments to Latin America and ensure that patients have access to therapies that have the potential to save their lives. Women throughout our region are facing increasing rates of HPV and the burden of cervical cancer," said Carlos Arenas, Chief Executive Officer of Stendhal. "It is through partnerships such as this one that we can alter the course of disease and address the health inequalities many in Latin America face."

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide. In the U.S., nearly 13,000 new cases are diagnosed annually and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Anal Cancer

Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one’s lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.

HPV-Associated Head and Neck Cancers

More than 90 percent of head and neck squamous cell oropharyngeal cancers originate from the mucosal linings of the oral cavity, pharynx, or larynx. Currently, 60 to 80 percent of these cancers are caused by HPV. Head and neck cancers are treated by surgical removal of the cancer and lymph nodes, often followed by radiation and chemotherapy based on the extent of the disease. While patients may achieve good long-term survival, standard treatments can change their physical appearance and are associated with significant short and long-term toxicities which may interfere with salivary gland function, taste, smell, and the ability to swallow.

The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the WHO, approximately 15 to 20 percent of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year and it affects men about 3 times more frequently than women. HPV-associated head and neck cancer is growing fastest in developed countries like the U.S.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of anal cancer.

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